Implantable shunt systems and methods

ABSTRACT

The present technology relates to interatrial shunting systems and methods. In some embodiments, the present technology includes interatrial shunting systems that include a shunting element having a lumen extending therethrough that is configured to fluidly couple the left atrium and the right atrium when the shunting element is implanted in a patient. The system can also include an energy receiving component for receiving energy from an energy source positioned external to the body, an energy storage component for storing the received energy, and/or a flow control mechanism for adjusting a geometry of the lumen.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.17/298,396, filed May 28, 2021, which claims the benefit of thefollowing pending applications:

(a) U.S. Provisional Patent App. No. 62/944,193, filed Dec. 5, 2019;

(b) U.S. Provisional Patent App. No. 62/952,894, filed Dec. 23, 2019;and

(c) U.S. Provisional Patent App. No. 62/952,903, filed Dec. 23, 2019.

All of the foregoing applications are incorporated herein by referencein their entireties. Further, components and features of embodimentsdisclosed in the applications incorporated by reference may be combinedwith various components and features disclosed and claimed in thepresent application.

TECHNICAL FIELD

The present technology generally relates to implantable medical devicesand, in particular, to implantable interatrial systems and associatedmethods for selectively controlling blood flow between the right atriumand the left atrium of a heart.

BACKGROUND

Heart failure is a medical condition associated with the inability ofthe heart to effectively pump blood to the body. Heart failure affectsmillions of people worldwide, and may arise from multiple root causes,but is generally associated with myocardial stiffening, myocardial shaperemodeling, and/or abnormal cardiovascular dynamics. Chronic heartfailure is a progressive disease that worsens considerably over time.Initially, the body's autonomic nervous system adapts to heart failureby altering the sympathetic and parasympathetic balance. While theseadaptations are helpful in the short-term, over a longer period of timethey may serve to make the disease worse.

Heart failure (HF) is a medical term that includes both heart failurewith reduced ejection fraction (HFrEF) and heart failure with preservedejection fraction (HFpEF). The prognosis with both HFpEF and HFrEF ispoor; one-year mortality is 26% and 22%, respectively, according to oneepidemiology study. In spite of the high prevalence of HFpEF, thereremain limited options for HFpEF patients. Pharmacological therapieshave been shown to impact mortality in HFrEF patients, but there are nosimilarly-effective evidence-based pharmacotherapies for treating HFpEFpatients. Current practice is to manage and support patients while theirhealth continues to decline.

A common symptom among heart failure patients is elevated left atrialpressure. In the past, clinicians have treated patients with elevatedleft atrial pressure by creating a shunt between the left and rightatria using a blade or balloon septostomy. The shunt decompresses theleft atrium (LA) by relieving pressure to the right atrium (RA) andsystemic veins. Over time, however, the shunt typically will close orreduce in size. More recently, percutaneous interatrial shunt deviceshave been developed which have been shown to effectively reduce leftatrial pressure. However, these percutaneous devices often have anannular passage with a fixed diameter which fails to account for apatient's changing physiology and condition. For this reason, existingpercutaneous shunt devices may have a diminishing clinical effect aftera period of time. Many existing percutaneous shunt devices typically arealso only available in a single size that may work well for one patientbut not another. Also, sometimes the amount of shunting created duringthe initial procedure is later determined to be less than optimal monthslater. Accordingly, there is a need for improved devices, systems, andmethods for treating heart failure patients, particularly those withelevated left atrial pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an interatrial device implanted ina heart and configured in accordance with select embodiments of thepresent technology.

FIG. 2 is a schematic illustration of an interatrial shunting systemconfigured in accordance with select embodiments of the presenttechnology.

FIG. 3 is a partially cut-away isometric view of an interatrial shuntingsystem configured in accordance with select embodiments of the presenttechnology.

FIGS. 4A-4C illustrate an interatrial shunting system configured inaccordance with select embodiments of the present technology.

FIGS. 5A and 5B illustrate an interatrial shunting system configured inaccordance with select embodiments of the present technology.

FIG. 6 illustrates an adjustable interatrial shunt device configured inaccordance with select embodiments of the present technology.

FIGS. 7A-7C are cross-sectional illustrations of the adjustableinteratrial device shown in FIG. 6 and configured in accordance withselect embodiments of the present technology.

FIGS. 8A-8C illustrate various aspects of a transseptal componentconfigured in accordance with select embodiments of the presenttechnology.

DETAILED DESCRIPTION

The present technology is generally directed to implantable shuntsystems and associated methods. The implantable shunt systems describedherein can be used to shunt bodily fluid such as blood between a firstbody region and a second body region. The implantable shunt systems caninclude, among other things, a shunting element defining a lumen forfluidly connecting the first body region and the second body region, anactuation mechanism for adjusting a geometry of the lumen, an energyreceiving component, an energy storage component, and/or one or moresensors.

For example, in some embodiments the present technology provides aninteratrial shunt system. The system includes a shunting elementimplantable into a patient at or adjacent to a septal wall. The shuntingelement can fluidly connect a LA and a RA of the patient to facilitateblood flow therebetween. For example, the shunting element can have alumen extending therethrough between a first orifice positionable in theLA and a second orifice positionable in the RA. The system can furtherinclude (i) an actuation mechanism configured to selectively adjust ageometry of the lumen, the first orifice, and/or the second orifice,(ii) an implantable energy receiving component configured to receiveenergy from an energy source positioned external to the patient, and(iii) an implantable energy storage component configured to store energyreceived by the implantable energy receiving component. The implantableenergy storage component can selectively release the stored energy topower the actuation mechanism and/or one or more active components ofthe system, such as one or more sensors.

The terminology used in the description presented below is intended tobe interpreted in its broadest reasonable manner, even though it isbeing used in conjunction with a detailed description of certainspecific embodiments of the present technology. Certain terms may evenbe emphasized below; however, any terminology intended to be interpretedin any restricted manner will be overtly and specifically defined assuch in this Detailed Description section. Additionally, the presenttechnology can include other embodiments that are within the scope ofthe examples but are not described in detail with respect to FIGS. 1-8C.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment of the present technology. Thus, the appearances of thephrases “in one embodiment” or “in an embodiment” in various placesthroughout this specification are not necessarily all referring to thesame embodiment. Furthermore, the particular features or characteristicsmay be combined in any suitable manner in one or more embodiments.

Reference throughout this specification to relative terms such as, forexample, “substantially,” “approximately,” and “about” are used hereinto mean the stated value plus or minus 10%.

As used herein, in various embodiments, the terms “interatrial device,”“interatrial shunt device,” “IAD,” “IASD,” “interatrial shunt,” and“shunt” are used interchangeably and, in at least one configuration,refer to a shunting element that provides a blood flow between a firstregion (e.g., a LA of a heart) and a second region (e.g., a RA orcoronary sinus of the heart) of a patient. Although described in termsof a shunt between the atria, namely the LA and the RA, one willappreciate that the technology may be applied equally to other medicaldevices. For example, the shunt may be positioned between other chambersand passages of the heart or other parts of the cardiovascular system.For example, any of the shunts described herein, including thosereferred to as “interatrial,” may be nevertheless used and/or modifiedto shunt between the LA and the coronary sinus, or between the rightpulmonary vein and the superior vena cava. Moreover, while thedisclosure herein primarily describes shunting blood from the LA to theRA, the present technology can be readily adapted to shunt blood fromthe RA to the LA to treat certain conditions, such as pulmonaryhypertension. For example, mirror images of embodiments, or in somecases identical embodiments, used to shunt blood from the LA to the RAcan be used to shunt blood from the RA to the LA in certain patients. Inanother example, the shunt may be used to facilitate flow between anorgan and organ, organ and vessel, etc. The shunt may also be used forfluids other than blood. The technologies described herein may be usedfor an ophthalmology shunt to flow aqueous or fluids to treatgastrointestinal disorders. The technologies described herein may alsobe used for controlled delivery of other fluids such as saline, drugs,or pharmacological agents.

As used herein, the terms “interatrial shunt system,” “interatrialshunting systems,” “shunting systems,” and the like are usedinterchangeably to refer to an implantable system that, among otherthings, includes an interatrial shunt (e.g., a shunting element).

As used herein, the term “geometry” can include the size and/or theshape of an element. Accordingly, when the present disclosure describesa change in geometry, it can refer to a change in the size of an element(e.g., moving from a smaller circle to a larger circle), a change in theshape of an element (e.g., moving from a circle to an oval), and/or achange in the shape and size of an element (e.g., moving from a smallercircle to a larger oval). In various embodiments, “geometry” refers tothe relative arrangements and/or positions of elements in the respectivesystem.

The headings provided herein are for convenience only and do notinterpret the scope or meaning of the claimed present technology.

A. Interatrial Shunts for Treatment of Heart Failure

Heart failure can be classified into one of at least two categoriesbased upon the ejection fraction a patient experiences: (1) HFpEF,historically referred to as diastolic heart failure or (2) HFrEF,historically referred to as systolic heart failure. One definition ofHFrEF is a left ventricular ejection fraction lower than 35%-40%. Thoughrelated, the underlying pathophysiology and the treatment regimens foreach heart failure classification may vary considerably. For example,while there are established pharmaceutical therapies that can help treatthe symptoms of HFrEF, and at times slow or reverse the progression ofthe disease, there are limited available pharmaceutical therapies forHFpEF with only questionable efficacy.

In heart failure patients, abnormal function in the left ventricle (LV)leads to pressure build-up in the LA. This leads directly to higherpressures in the pulmonary venous system, which feeds the LA. Elevatedpulmonary venous pressures push fluid out of capillaries and into thelungs. This fluid build-up leads to pulmonary congestion and many of thesymptoms of heart failure, including shortness of breath and signs ofexertion with even mild physical activity. Risk factors for HF includerenal dysfunction, hypertension, hyperlipidemia, diabetes, smoking,obesity, old age, and obstructive sleep apnea. HF patients can haveincreased stiffness of the LV which causes a decrease in leftventricular relaxation during diastole resulting in increased pressureand inadequate filling of the ventricle. HF patients may also have anincreased risk for atrial fibrillation and pulmonary hypertension, andtypically have other comorbidities that can complicate treatmentoptions.

Interatrial shunts have recently been proposed as a way to reduceelevated left atrial pressure, and this emerging class of cardiovasculartherapeutic interventions has been demonstrated to have significantclinical promise. FIG. 1, for example, shows the conventional placementof a shunt in the septal wall between the LA and RA. Most conventionalinteratrial shunts (e.g., shunt 10) involve creating a hole or insertingan implant with a lumen into the atrial septal wall, thereby creating afluid communication pathway between the LA and the RA. As such, elevatedleft atrial pressure may be partially relieved by unloading the LA intothe RA. In early clinical trials, this approach has been shown toimprove symptoms of heart failure.

One challenge with many conventional interatrial shunts is determiningthe most appropriate size and shape of the shunt lumen. A lumen that istoo small may not adequately unload the LA and relieve symptoms; a lumenthat is too large may overload the RA and right-heart more generally,creating new problems for the patient. Moreover, the relationshipbetween pressure reduction and clinical outcomes and the degree ofpressure reduction required for optimized outcomes is still not fullyunderstood, in part because the pathophysiology for HFpEF (and to alesser extent, HFrEF) is not completely understood. As such, cliniciansare forced to take a best guess at selecting the appropriately sizedshunt (based on limited clinical evidence) and generally cannot adjustthe sizing over time. Worse, clinicians must select the size of theshunt based on general factors (e.g., the size of the patient'sanatomical structures, the patient's hemodynamic measurements taken atone snapshot in time, etc.) and/or the design of available devicesrather than the individual patient's health and anticipated response.With traditional devices, the clinician does not have the ability toadjust or titrate the therapy once the device is implanted, for example,in response to changing patient conditions such as progression ofdisease. By contrast, interatrial shunting systems configured inaccordance with embodiments of the present technology allow a clinicianto select the size—perioperatively or post-implant—based on the patient.

A further challenge with conventional interatrial shunts is thatfunction of the LA (and more generally, the cardiovascular system) canvary depending on a number of factors, for example during exercise,during periods where a patient's medication adherence has slipped, asthe patient's disease progresses, or during other periods. Existingconventional shunts are generally static in nature and lack an abilityto adapt to patient conditions in such a way to optimize therapy.

Other shortcomings of existing conventional interatrial shunts include:(1) shunts tending to be permanently implanted in the septal wall in away that complicates or prevents future transseptal access, which mayprohibit or complicate additional left-heart procedures that generallywould require transseptal access; (2) shunts tending to be fixed andunable to adapt to changing patient conditions, such as progression ofdisease, and (3) a lack of sensors and/or machine-learning capabilitythat limit the information available from the patient and limit theability to improve therapy for the patient (or for the larger patientcohort) over time.

B. Interatrial Shunt Systems

As provided above, the present technology is generally directed toimplantable shunt systems, such as implantable interatrial shuntsystems. FIG. 2 is a schematic illustration of an interatrial shuntingsystem 200 (“system 200”) configured in accordance with embodiments ofthe present technology. The system 200 includes a shunting element ordevice 202 defining a lumen 204 therethrough. The shunting element 202can include a first end portion 203 a positionable in the LA and asecond end portion 203 b positionable in the RA. Accordingly, whenimplanted in the septal wall S, the system 200 fluidly connects the LAand the RA via the lumen 204. When the system 200 is implanted to treatHFpEF, blood generally flows through the lumen 204 in flow direction F(i.e., from the LA to the RA). Under varying subject conditions, thelumen 204 may enable flow in the opposite direction (i.e., from the RAto the LA), or in both directions as the pressure gradient betweenchambers alternates.

The shunting element 202 can be stabilized in position through forcesapplied by aspects of the system (e.g., by a flow control mechanism 250,described below) to regions of tissue (e.g., a septal wall) and/or besecured in place by one or more anchoring element(s). For example, thesystem 200 can include one or more first anchoring elements 220 apositioned on the LA side of the septal wall S and/or one or more secondanchoring elements 220 b positioned on the RA side of the septal wall S(collectively referred to as anchoring elements 220). The firstanchoring elements 220 a may engage a portion of the septal wall Sfacing the LA and the second anchoring elements 220 b may engage aportion of the septal wall S facing the RA. In some embodiments, theanchoring elements 220 do not make direct contact with a tissue wall. Insome embodiments, the anchoring elements 220 extend from and/or areintegral with aspects of the shunting element 202. This may be a directconnection via a process such as welding, via an adhesive, or viaanother connection mechanism known to those skilled in the art.Alternatively, the shunting element 202 and the anchoring elements 220may be comprised of a single structure, such as a unitary structurecomposed of a superelastic alloy (e.g., nitinol), and treated so eachportion of the device takes on the desired shape. In variousembodiments, a connecting element such as a strut or arm may be used toconnect the anchoring elements 220 to a horizontal body portion of theshunting element 202. This horizontal body portion may be transseptal,partially-transseptal, or may lie predominantly on one side of theseptal wall S, and may have a generally tubular shape that defines thelumen 204. In some embodiments, the system 200 includes a stent-likestructure that includes the anchoring elements 220 and an outer frameportion (not shown) that directly interfaces with the septal wall S. Insome embodiments, the outer frame portion may be distinct from theseparate horizontal body portion that serves as a fluid communicationlumen, as described in greater detail with respect to FIGS. 6-7B.

In some embodiments, the shunting element 202 is anchored in place usingone or more anchoring elements positioned on only one side of the septalwall S. In yet other embodiments, the system 200 does not include firstand second anchoring elements 220 a and 220 b and the shunting element202 is secured in place by its general shape, by exerting a radiallyoutward pressure, by another component of the system 200, and/or byother suitable mechanisms.

The system 200 further includes various electronic components. Forexample, the system 200 can include one or more energy receivingcomponents 230 and one or more energy storage components 232. Asdiscussed in greater detail below, the one or more energy receivingcomponents 230 can be configured to (i) receive energy from an energysource positioned external to a patient's body, and/or (ii) generateenergy when exposed to a magnetic or electric field generated by theenergy source positioned external to the implanted components of thesystem (e.g., generated by a source external to the patient's body,generated by a catheter inside the patient's body, etc.). In someembodiments, the energy receiving component 230 can be configured toreceive energy transmitted in the radiofrequency (RF) frequency range,including in the high frequency RF range (e.g., between 3-30 MHz) and/orthe ultra-high frequency RF range (e.g., 300-3,000 MHz). In otherembodiments, the energy receiving component 230 can be configured toreceive magnetic or other forms of energy (e.g., heat). The energyreceiving component 230 can be a metallic coil, wire, or other antenna,and may be composed at least in part of a high conductivity metal suchas copper, silver, or composites thereof. In some embodiments, theenergy receiving component 230 may be a generally circular loop or coilof multiple loops coaxial with the lumen 204. In other embodiments, theenergy receiving component 230 may be an oval or other non-circular loopor coil of multiple loops bent around the lumen 204. Another embodimentmay include a combination of the foregoing loop or coil of multipleloops configured to couple to an external magnetic field regardless oforientation. In some embodiments, a portion of the shunt structure(e.g., anchor elements 220) may serve as all or part of the coil orantenna.

The energy storage components 232 can be configured to store energyreceived and/or generated by the energy receiving component 230. Theenergy storage components 232 can include a battery, a supercapacitor, acapacitor, and/or other suitable elements that can retain energy. Asdescribed below, the energy received by the energy receiving component230 and/or stored within the energy storage components 232 can be used(i) to actuate a flow control mechanism 250 to adjust a geometry of thelumen 204 (and/or a geometry of the lumen orifice), thereby altering theflow of blood through the lumen 204, (ii) to power various implantedelectronic components, such as sensors 240 described below, and/or (iii)for other operations requiring an energy input.

In some embodiments, the system 200 includes more than one energyreceiving component 230. For example, the system 200 can include a firstenergy receiving component and a second energy receiving component. Thefirst energy receiving component and the second energy receivingcomponent can both be in electrical communication with the energystorage component 232. The first energy receiving component can beconfigured to receive energy from one or more external sourcesconfigured to interface or otherwise communicate with the first energyreceiving component. For example, the one or more external sources caninclude an energy source positioned external to the body and configuredto deliver energy remotely to the energy receiving component and/or acatheter that docks or otherwise interfaces with the energy receivingcomponent. The second energy receiving component can be configured toreceive energy from the energy storage component 232. Accordingly,energy can be transferred from an external source to the first energyreceiving component, from the first energy receiving component to theenergy storage component, and from the energy storage component to thesecond energy receiving component. In some embodiments, the secondenergy receiving component can be part of the flow control mechanism250, described below. In some embodiments, a component maysimultaneously and/or alternatingly serve as both an energy receivingcomponent and an energy storage component.

The first energy receiving component may be a combination of conductive(e.g. wire or PCB monopole or dipole antenna) and dielectric (e.g.dielectric rod antenna) elements capable of extracting energy from anelectromagnetic field, or a conductive element (e.g. wire coil) capableof extracting energy from an AC magnetic field. In some embodiments, thefirst energy receiving component has substantially no temperature risewhen it receives energy, but the second energy receiving component doeshave a temperature rise when it receives energy. In such embodiments,the first energy receiving component may receive energy from an externalsource and store it without meaningful dissipation (e.g. dissipation ofless than 10%, 15%, or 20% of the total received energy), and latertransfer it to the second energy receiving component which dissipates itintentionally. For example, the second energy receiving component mayinclude a temperature sensitive shape memory alloy material that cantransition between various configurations when heat is applied. In someembodiments, the first energy receiving component and second energyreceiving component can receive energy via pulses occurring at differentfrequencies. For example, the first energy receiving component canreceive energy delivered at a first frequency, and the second energyreceiving component can receive energy delivered at a second frequencydifferent than the first frequency. In some embodiments, the secondenergy receiving component receives a direct current signal. In someembodiments, the first energy receiving component receives analternating current signal. In some embodiments, the second energyreceiving component may directly receive AC energy from an externalsource. One or more of the electrical components (e.g., the energyreceiving components or the energy storage components) can extend alongan axial length of the septal implant lumen.

Accordingly, the septal implants described herein can receive energyfrom an external source and store the energy on the implant in an energystorage component. Upon selective activation, the energy storagecomponent releases the energy in discrete portions. The discreteportions can be defined by the amount of energy released and/or the timeperiod of energy release (e.g., 200 ms or less). In some embodiments,the energy may be selectively released to more than one second energyreceiving component and/or to more than one location on the secondenergy receiving component. In some embodiments, an energy storagecomponent may be pre-loaded with energy and therefore not be configuredto receive energy from an external source. For example, the energystorage component can be fully charged or substantially fully chargedwhen implanted in the patient.

In some embodiments, the system 200 includes more than one energystorage component 232. For example, the system 200 can include a firstenergy storage component and a second energy storage component. In someembodiments, the first energy storage component is “energy dense” andthe second energy storage component is “power dense.” The term “energydense” refers to the amount of energy in a given mass or volume, whilethe term “power dense” refers to the amount of power in a given mass orvolume. In embodiments in which the first energy storage component isenergy dense, the first energy storage component can be a battery. Inembodiments in which the second energy storage component is power dense,the second energy storage component can be a capacitor. Moreover, inembodiments having more than one energy storage component, one of theenergy storage components (e.g., the first energy storage component) canbe a primary, non-rechargeable component and another of the energystorage components (e.g., the second energy storage component) can be asecondary, rechargeable component. Furthermore, at the time when thesystem 200 is implanted, the first energy storage component (e.g., thebattery) can be at or near its full stored energy capacity and thesecond energy storage component (e.g., the capacitor) can besubstantially devoid of stored energy. In such embodiments, the secondenergy storage component can be charged after the implant procedure. Insome embodiments, the second energy storage component can be chargedusing an energy source positioned external to the body. In otherembodiments, the second energy storage component can be charged usinginvasive charging mechanisms, such as a catheter coupled to a powersource. In such embodiments, the catheter can dock or otherwiseinterface with one or more implanted aspects of the system 200 to chargethe second energy storage component.

In some embodiments, the energy storage component 232 can be charged(initially charged, recharged, etc.) using an energy source positionedexternal to the implanted device, for example a source positionedexternal to the patient. In some embodiments, the charging is conducteddirectly. In alternative embodiments, the charging is conducted byelectrically connecting the energy storage component 232 to the energyreceiving component 230, which captures energy from the external source,converts it to an appropriate form, and provides it to the energystorage component 232. In some embodiments the energy storage component232 may be a secondary (rechargeable) cell (battery), such as aLithium-Polymer or Lithium-Ion cell. In various embodiments the energystorage component 232 can be a supercapacitor (double electric-layercapacitor). In various embodiments the energy storage component 232 canbe a combination of a supercapacitor and conventional capacitor, such asan aluminum electrolytic capacitor, tantalum electrolytic capacitor, ormultilayer ceramic capacitor. In some embodiments, the energy receivingcomponent 230 may receive AC magnetic or electromagnetic energy from anexternal energy source. The received AC energy may be converted to DCusing synchronous or non-synchronous (diode) rectification. In someembodiments, the converted DC energy may be boosted and regulated to alevel suitable for use by an implanted processor and other implantedelectronics via a boost, buck-boost, SEPIC, Zeta, charge pump, or otherswitch-mode power conversion circuit. In various embodiments, theexternally generated magnetic or electromagnetic field can be modulatedby the energy source to encode data for transmission to the implantedelectronics. In various embodiments, the load presented by the implantedelectronics may be modulated to convey data to the external equipmentgenerating the magnetic or electromagnetic field. In variousembodiments, NFC (nearfield communications) techniques may be used toimplement energy and/or data transfer.

In some embodiments, the energy storage component 232 can be configuredto promote tissue ingrowth and/or overgrowth to become endothelializedby local tissue. For example, the energy storage component 232 can becoated with a material that promotes tissue ingrowth and/or can includevarious structures (e.g., lattices, mesh, and the like) that promotetissue ingrowth. In some embodiments, the energy storage component 232includes an outer jacket material configured to promoteendothelialization. In some embodiments, the energy storage component232 can have a roughened surface (e.g., via bead blasting, knurling,chemical etching, etc.) that promotes endothelialization. Without beingbound by theory, endothelization of the energy storage component 232 mayreduce the thrombogenicity of the energy storage component 232 and/ormay help secure the energy storage component 232 and other implantedcomponents of the system 200 in a target position.

In some embodiments, the one or more energy storage components 232 canbe coupled to or otherwise interface with the anchoring elements 220.For example, the energy storage component 232 can interface with asurface of the septal wall S, and the anchoring elements 220 caninterface with the energy storage component 232 such that the anchoringelement 220 do not directly engage the septal wall S.

The system 200 can also include one or more sensors (e.g., a firstsensor 240 a, a second sensor 240 b, etc.; collectively referred to asthe sensors 240). The sensors 240 can be configured to measure one ormore physiologic parameters related to the system 200 or the environmentproximate to the sensors 240, such as local blood pressure (e.g., LAblood pressure, RA blood pressure, etc.), flow velocity, pH, SpO2, SpC,SpMet, heart rate, cardiac output, myocardial strain, etc. The sensorscan be, for example, (1) embedded in an implantable component of thesystem 200, (2) implanted yet spaced apart from other implantablecomponents of the system 200, and/or (3) included on a wearable patch ordevice external to the body. If included on a wearable patch or device,the wearable patch or device could provide power to the sensor (e.g.,RFID/NFC). In some embodiments, the wearable patch or device can alsoread sensor data. The sensors can be continuously recording or can beturned on at select times.

In one embodiment, the first sensor 240 a is a pressure sensorpositionable within the LA and the second sensor 240 b is a pressuresensor positionable within the RA. In some embodiments, the system 200can further include a processor (not shown) configured to calculate apressure differential between the LA and the RA based on informationmeasured by the sensors 240 or other information. As described below,the system 200 may be adjusted based on the parameters measured by thesensors 240 and/or the pressure differential or other informationcalculated by the processor.

In some embodiments, the sensors 240 may be configured as pressuresensors. For example, the pressure sensor can include a cavity coveredby a membrane, where the membrane communicates with a strain sensingelement, an element that varies the frequency of a resonant circuit,and/or other elements that vary with the deflection of the membrane andalter an electrically measurable quantity. The membrane may be in directcontact with a measurement region, conformally coated with a materialdirectly in contact with a measurement region, and/or enclosed in arigid vessel filled with a fluid communicating with a membrane that isin contact with a measurement region, where the fluid may be a liquidsuch as silicone oil or a gas such as air. Embodiments with a sensor ora conformally coated sensor directly in contact with a measurementregion will additionally incorporate a means of communicating pressureinformation to electronics enclosed in a housing.

The system 200 also includes a flow control mechanism 250 (e.g., anactuation mechanism, a flow control assembly, an actuation assembly,etc.). The flow control mechanism 250 is configured to selectivelychange a geometry or other characteristic of the shunting element 202and/or the lumen 204 to change the flow of fluid through the lumen 204.For example, the flow control mechanism 250 can be configured toselectively increase a diameter of the lumen 204 (or lumen orifice)and/or selectively decrease a diameter of the lumen 204 (or lumenorifice) in response to an input. In other embodiments, the flow controlmechanism 250 is configured to otherwise affect a geometry of the lumen204. Accordingly, the flow control mechanism 250 can be coupled to theshunting element 202 and/or can be included within the shunting element202. For example, in some embodiments the flow control mechanism 250 ispart of the shunting element 202 and at least partially defines thelumen 204. In other embodiments, the flow control mechanism 250 isspaced apart from but operably coupled to the shunting element 202.

In some embodiments, at least a portion of the flow control mechanism250 can comprise a shape memory material. The shape memory portion caninclude nitinol, a nitinol-based alloy, a shape memory polymer, apH-based shape memory material, or any other suitable materialconfigured to move or otherwise adjust as would be understood by one ofskill from the description herein. The shape memory portion can becharacterized by a curve that defines the amount of deformation theportion undergoes in response to a particular input (e.g., an appliedstress). For example, the flow control mechanism 250 can include anitinol element that is configured to change shape in response toexposure to energy, such as heat. In such embodiments, the flow controlmechanism 250 can be selectively actuated by applying energy directly orindirectly to the nitinol element. Additional features and examples offlow control mechanisms incorporating one or more shape memorycomponents are described in International Patent Application No.PCT/US2020/049996, the disclosure of which is incorporated by referenceherein in its entirety.

In some embodiments, the flow control mechanism 250 includes an activemotor that is operably coupled to one or more actuation elements thatchange flow through the lumen 204. Suitable motors includeelectromagnetic motors, implanted battery and mechanical motors, MEMSmotors, micro brushless DC motors, piezoelectric based motors,solenoids, and other motors. The flow control mechanism 250 can takeother suitable forms as well. Additional features and examples ofshunting devices having flow control mechanisms are described inInternational Patent Application No. PCT/US2020/038549, the disclosureof which is incorporated by reference herein in its entirety.

In some embodiments, the flow control mechanism 250 can be actuatedusing energy stored in the energy storage component 232. Accordingly,rather than directly applying energy to the flow control mechanism 250,a clinician can use a controller (described below) to actuate the flowcontrol mechanism 250 (thereby adjusting the geometry of the shuntingelement 202 and/or the lumen 204) using energy stored in the energystorage component 232. This permits the clinician to decouple theprocess of (1) applying energy to the energy receiving component 230,and (2) adjusting the shunting element 202. Accordingly, the energystorage component 232 may store energy for a period of time (e.g.,minutes, hours, days, months, etc.) and, upon a determination that theflow through the shunting element 202 should be changed, a user candirect the energy storage component 232 to release stored energy anddirect it to one or more aspects of the flow control mechanism 250. Inother embodiments, the system 200 can automatically direct the energystorage component 232 to release stored energy and direct it the flowcontrol mechanism 250 to adjust a flow through the shunting element 202.

In one embodiment, the energy storage component 232 can be configured todischarge energy (e.g., in the form of a discharge pulse) to heat anactuation element of the flow control mechanism 250. For example, theenergy storage component 232 may discharge energy to one or moreactuation elements that are composed of a metallic material such thatapplying energy to the metallic material leads to resistive heating,inductive heating, or both. The metallic material can be a shape memorymaterial such as nitinol that has been manufactured such that theresistive heating results in at least a partial transition of thematerial from a first material phase or state (e.g., martensitic phase,R-phase, etc.) to a second material phase or state (e.g., an R-phase, anaustenitic phase, etc.). If the shape memory actuation element isdeformed relative to its preferred geometry (e.g., manufacturedgeometry, original geometry, heat-set geometry, shape-set geometry,etc.), transitioning the shape memory actuation element from the firstmaterial phase to the second material phase can induce a geometricchange in the shape memory actuation element to and/or toward itspreferred geometry. The heat can therefore be applied to the one or moreshape memory actuation elements to affect a property of said component(e.g., a length, width, position, stiffness, etc.). The movement of theshape memory actuation element can result in a change of the shape ordimension of the lumen 204. In some embodiments, the heated element(e.g., the shape memory actuation element) is different than themechanism that moves to change the geometry of the shunting element 202and/or the lumen 204. For example, the actuation element may bemechanically connected to connecting features that translate themovement of the actuation element into a change in a feature (e.g., achange in size, shape, etc.) of a different component of the device(e.g. a horizontal lumen component), as described below with referenceto FIGS. 8A-8C.

In another embodiment, energy stored in energy storage components istransferred into a region of the shunting element 202 containing amaterial that softens or melts when heated (e.g., a wax or similarcomponent). The softened material can enable adjustments to be made toone or more components of the device (e.g., thereby changing the shape,length, orientation, or position of the component, as described herein).Once energy is no longer being applied to this region of the shuntingelement 202, the material can regain its original mechanical properties(e.g., re-hardens) and any adjustments made to components are held inplace.

In some embodiments, the energy storage component 232 and/or the energyreceiving component 230 can be omitted and flow can be adjusted bydirectly applying energy to the flow control mechanism 250. In suchembodiments, a portion of the flow control mechanism 250 can beconfigured to receive energy (e.g., heat, light, RF, ultrasound,microwave, etc.) from an energy source positioned external to the body(e.g., an RF transmitter) and, in response to the received energy,adjust the flow through the lumen 204. For example, the flow controlmechanism 250 can include a heat activated shape memory element, andadjusting the lumen 204 via the flow control mechanism 250 can compriseheating the shape memory element to change the geometry of the shapememory alloy element, thereby adjusting flow through the shuntingelement 202, as previously described.

In some embodiments, the flow control mechanism 250 is coupled to aprocessor (not shown) that calculates the pressure differential betweenthe LA and RA based, at least in part, on the measurements taken by thesensors 240. If the calculated pressure differential falls outside of apredetermined range, the processor can direct the flow control mechanism250 to change the flow through the shunting element 202. In someembodiments, the sensors 240, the processor, and the flow controlmechanism 250 operate in a closed-loop system to adjust the shuntingelement 202. In other embodiments, the pressure differential sensed bythe sensors 240 is transmitted to a display external to the patient, anda user (e.g., a clinician) adjusts the flow through the shunting element202 based at least in part on the measured pressure differential. Insuch embodiments, the physician may adjust the flow using a non-invasiveenergy source (e.g., an RF transmitter) and/or by interfacing with acontroller 260 (described below).

As provided above, the system 200 can include a controller 260connectable to or integrated with one or more implanted aspects of thesystem 200. Suitable controllers include, for example, mobile deviceapplications, computers, dedicated controllers, etc. The controller 260can connect to various implanted aspects of the system 200 via WiFi,Bluetooth (e.g., BLE 5.0), electromagnetic, ultrasound, radiofrequency,or other wireless means. Alternatively, the controller 260 may becoupled to implanted aspects via a wired connection. The controller 260provides a user interface such that a user (e.g., the patient, aphysician, etc.) can selectively control the system 200 via thecontroller. For example, a physician can input a desired flow rate,pressure/pressure gradient, or other input, and the controller 260 cancommunicate (either directly or indirectly) with the flow controlmechanism 250 such that the flow control mechanism 250 manipulates theshunting element 202 to achieve a desired flow rate and/or flowresistance through the shunting element 202.

As discussed above, the controller 260 may be coupled to variousimplanted aspects of system 200 via a combination of wired and wirelessconnections. Distributing the communication across multiple devicesand/or modalities may provide improved flexibility and power savings. Itis understood that wireless communication with “deep” implants wellbelow the skin (e.g., the implanted components of the system 200)present greater challenges with wireless data and power transmission. Insome embodiments, the system 200 may utilize wireless technology toconnect external components with a hub and wired technology to connectthe hub to the device electronics. For example, the system 200 maycommunicate to a subcutaneous device via a wired connection, and thesubcutaneous device communicates to an external device via a wirelessconnection, or vice versa.

Some embodiments of the present technology adjust the geometry of theshunting element 202 and/or the lumen 204 consistently (e.g.,continuously, hourly, daily, etc.). Consistent adjustments might bemade, for example, to adjust the flow of blood based on an exertionlevel and/or heart rate of the patient, which changes frequently overthe course of a day. For example, the system 200 can have a baselinestate in which the lumen 204 is substantially closed and does not allowsubstantial blood flow between the LA and RA, and an active state inwhich the lumen 204 is open and allows blood to flow between the LA andRA. The system 200 can transition from the baseline state to the activestate whenever the exertion level (e.g. as measured by the heart rate)of the patient increases due to exercise, stress, or other factors. Inanother embodiment, consistent adjustments can be made based on, or inresponse to, sensed physiological parameters, including, for example,sensed LA pressure and/or RA pressure via sensors 240. If the LApressure increases, the system 200 can automatically increase a diameterof the lumen 204 between the LA and the RA and allow increased bloodflow. In another example, the system 200 can be configured to adjustbased on, or in response to, an input parameter from another device suchas a pulmonary arterial pressure sensor, insertable cardiac monitor,pacemaker, defibrillator, cardioverter, wearable, external ECG or PPG,and the like.

Some embodiments of the present technology adjust the geometry of thelumen 204 only after a threshold has been reached (e.g., a sufficientperiod of time has elapsed). This may be done, for example, to avoidunnecessary back and forth adjustments and/or avoid adjustments based onclinically insignificant changes. In some embodiments, adjustments mayoccur occasionally as a patient's condition changes, for example thelumen 204 may gradually open if a patient experiences a sustained risein LA pressure (e.g., rate of change is above a predetermined threshold,or the LA pressure remains higher than a predetermined threshold forlonger than a predetermined amount of time), pulmonary artery pressure,weight, or another physiologically relevant parameters. Additionally oralternatively, adjustments can occur if pressure exceeds a threshold orincreases by a threshold amount over a period of time (e.g., severaldays or more). The geometry of the lumen 204 is then adjusted (e.g., thediameter of the lumen 204 is increased) to increase blood flow betweenthe LA and RA and to avoid decompensation. When the patient isconsidered stable (e.g., if pressure or another parameter returns tonormal levels), the geometry of the lumen 204 can once again be adjustedinto the smaller, previous configuration.

The system 200 can also enable a clinician to periodically (e.g.,monthly, bi-monthly, annually, as needed, etc.) adjust the geometry ofthe lumen 204 to improve patient outcomes. For example, during a patientvisit, the clinician can assess a number of patient parameters anddetermine whether adjusting the geometry of the lumen 204, and thusaltering blood flow between the LA and the RA, would provide bettertreatment and/or enhance the patient's quality of life. Patientparameters can include, for example, physiological parameters (e.g., LAblood pressure, RA blood pressure, the difference between LA bloodpressure and RA blood pressure, flow velocity, heart rate, cardiacoutput, myocardial strain, etc.), subjective parameters (e.g., whetherthe patient is fatigued, how the patient feels during exercise, etc.),and other parameters known in the art for assessing whether a treatmentfor HFpEF is working. If the clinician decides to adjust the diameter ofthe lumen 204, the clinician can adjust the device lumen using thetechniques described herein.

FIG. 3 is a partially cut-away isometric view of an interatrial shuntingsystem 300 (“system 300”) configured in accordance with selectembodiments of the present technology. Similar to the system 200, thesystem 300 includes a shunting element 302 that can traverse the septalwall S such that a first end portion 303 a resides within the LA and asecond end portion 303 b resides within the RA. The shunting element 302can include a lumen 304 extending between the first end portion 303 aand the second end portion 303 b to direct fluid between the LA and theRA. The shunting element 302 can include a membrane 310 that at leastpartially encompasses aspects of the shunting element 302 and/or atleast partially defines the lumen 304. The shunting element 302 issecured in position by first anchoring elements 320 a and/or secondanchoring elements 320 b.

The system 300 further includes a housing 325. The housing 325 isillustrated as traversing the septal wall S, although in otherembodiments the housing 325 can reside within a heart chamber (e.g.,within the RA, within the LA, etc.) and/or can be positioned within orupon the septal wall S. In some embodiments, the system 300 can includemultiple housings 325. In the illustrated embodiment, the housing 325 isat least partially spaced apart from the shunting element 302, althoughin other embodiments the housing 325 is coupled to the shunting element302 or is integral with the shunting element 302. An outer surface ofthe housing 325 can comprise a biocompatible material that promotestissue ingrowth to secure the housing 325 in place.

The housing 325 can define a fluidly isolated chamber for storingvarious system components, such as electrical components 326 a-c(collectively referred to as electrical components 326). The electricalcomponents 326 can include, among other things, an energy receivingcomponent (e.g., the energy receiving component 230, shown in FIG. 2),an energy storage component (e.g., the energy storage component 232,shown in FIG. 2), a microcontroller or processor, one or more sensors(e.g., sensors 240, shown in FIG. 2), a motor, or other systemcomponent(s). In some embodiments, the housing 325 can include a firstsensor (e.g., electrical component 326 a) configured to be positionedwithin the LA for monitoring LA pressure and a second sensor (e.g.,electrical component 326 c) configured to be positioned within the RAfor monitoring RA pressure. As discussed above, the sensors can beconfigured to determine a pressure differential between the LA and theRA. Without being bound by theory, having multiple sensors locatedwithin a single housing component that traverses the septal wall isuseful because it enables multi-heart chamber measurements whilelimiting the overall size of the implanted aspects of the system 300 andreducing the complexity of the delivery procedure. Such a system alsoreduces the number of components and connections required to power andoperate sensors that are performing measurements in multiple heartchambers, which increases the reliability of the system. In someembodiments, the system 300 further includes a separate energy storagecomponent 332 (e.g., a battery, a supercapacitor, etc.).

The system 300 can further include a flow control mechanism (not shown),such as the flow control mechanism 250 described with respect to thesystem 200. The flow control mechanism can be included on and/oroperably coupled to the shunting element 302 and can actively adjust ageometry of the lumen 304. In some embodiments, for example, the flowcontrol mechanism, when actuated, manipulates one or more structuralelements defining the lumen 304 and/or the shunting element 302. In someembodiments, the flow control element can include a shape memoryactuator and/or a motor, as previously described. In some embodiments,one or more components of the flow control mechanism (e.g., a motor) canbe positioned within the housing 325. The components positioned withinthe housing 325 can be coupled to the shunting element 302 (e.g.,wirelessly coupled, wired, etc.) to change the shape and/or size of thelumen 304 to adjust the flow resistance therethrough.

FIGS. 4A-4C illustrate an interatrial shunting system 400 (“system 400”)configured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 4A is an isometric view of thesystem 400 from a left side of the septal wall S (e.g., viewed from theLA), FIG. 4B is an isometric view of the system 400 from a right side ofthe septal wall S (e.g., viewed from the RA), and FIG. 4C is across-sectional view of the system 400 from the left side of the septalwall S. The system 400 can have similar components to those discussedwith respect to systems 200 and 300. For example, implementations ofsystem 400 can include, among other things, a shunting element 402having a lumen 404 extending therethrough, anchoring elements 420, ahousing 425, an energy receiving component 430, a first energy storagecomponent 432 a, and a second energy storage component 432 b. Theshunting element 402 is positionable across the septal wall S to fluidlyconnect the RA and the LA. The housing 425 can also traverse the septalwall S such that a first end portion 425 a resides within a first heartchamber (e.g., the LA) and a second end portion 425 b resides within asecond heart chamber (e.g., the RA). As discussed with respect to FIG.3, the housing 425 can include a fluidically isolated environment forstoring various electronic components, such as sensors 440 shown in FIG.4C. The system may contain additional components, such as amicrocontroller/processor and/or a controller. In some embodiments, somestructures of the system may be covered with materials in order toreduce thrombogenicity, to encourage laminar flow of fluids through oraround the implant, to promote endothelialization, or for other reasons.For example, in some embodiments, some structural components may becovered with a biocompatible and/or flexible material such as ePTFE,PTFE, or the like.

The one or more sensors 440 can be adapted to measure a parameterrelated to the device or the environment proximate to the sensor. Insome embodiments, the system 400 contains one or more pressure sensorsadapted to measure local pressure levels. In other embodiments, multiplepressure sensors may be included, such as the sensors 440 attached to orcontained within enclosed housing 425. In some embodiments, a firstpressure sensor is included in the first end portion 425 a of thehousing 425 to measure a pressure on a first side of the septal wall S,and a second pressure sensor is included in the second end portion 425 bto measure a pressure on a second side of the septal wall S. Asdescribed above, the parameters sensed by the sensors can be used tocalculate a pressure differential between two or more heart chambers. Ifnecessary, the flow through the shunting element 402 can be adjustedbased on the pressure differential. As shown in FIG. 4C, the housing 425may span the entire length of the septal wall S such that the first endportion 425 a and the second end portion 425 b are each exposed to theenvironment in a chamber of the heart. In other embodiments, the housing425 may traverse only a portion of the septal wall S, or may resideentirely in a single chamber of the heart. In various embodiments, thehousing 425 may extend beyond the septal wall S into each of the LA andRA. In some embodiments, the system 400 can include multiple, distincthousings 425.

In various embodiments, the lumen 404 may be longer than the septal wallthickness. In various embodiments, the lumen 404 may extend beyond theface of the septal wall into one or both of the LA and RA. In variousembodiments, the first sensor, second sensor, or both are positionedwithin the lumen 404. In various embodiments, the first sensor, secondsensor, or both are positioned within an area defined by the septaldefect or septal wall. In various embodiments, the first sensor, secondsensor, or both are positioned outside an area defined by the septalwall and within the respective atrial chamber. In various embodiments,the housing 425 may include projections that extend off of the mainhousing body, for example extensions positioned to limit the amount oftissue overgrowth that will cover them. In yet other embodiments, thesystem 400 can include multiple, distinct housings 425.

The energy receiving component 430 can be a metallic loop or coil ofmultiple loops or other wire adapted to receive electromagnetic or otherenergy transmitted to the system 400 from an external source. In someembodiments, the loop or coil may be adapted to receive energytransmitted in the RF frequency range. In some embodiments, the energyreceiving component 430 is comprised of a material such as copper oranother suitable material, and can be collapsible within a deliverycatheter, for example a catheter with an outer diameter no larger than16 Fr, 18 Fr, 20 Fr, 24 Fr, 26 Fr, 27 Fr, 28 Fr, 29 Fr, 30 Fr, 35 Fr, or40 Fr. In some embodiments, the energy receiving component 430 isconfigured to lie substantially flat against the septal wall S whendeployed from the delivery catheter (e.g., protruding less than 2 mminto one of the chambers of the heart). In some embodiments, this may beaccomplished by mechanically-coupling one or more points of the energyreceiving component 430 to the anchoring elements 420, as illustrated inFIG. 4A. In the illustrated embodiment, the energy receiving component430 is illustrated on the LA side of the septal wall S, although inother embodiments the energy receiving component may be positioned onthe RA side of the septal wall S.

In some embodiments, the first energy storage component 432 a and thesecond energy storage component 432 b (collectively referred to asenergy storage components 432) are positioned on an opposite side of theseptal wall S relative to the energy receiving component 430. Forexample, in the illustrated embodiment the energy storage components 432are positioned on a RA side of the septal wall S and the energyreceiving component 430 is positioned on a LA side of the septal wall.Without being bound by theory, positioning energy capture and energystorage components on opposing sides of the septal wall can usefulbecause it may allow for a geometry that facilitates the physics ofenergy transfer while allowing the overall size of the implantedcomponents of the system 400 to remain relatively small. In otherembodiments, however, the energy receiving component 430 may bepositioned on the same side of the septal wall as one or more of theenergy storage components 432.

FIGS. 5A and 5B illustrate an interatrial shunting system 500 (“system500”) configured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 5A is an isometric view of thesystem 500 from a left side of the septal wall S (e.g., viewed from theLA), and FIG. 5B is a side view of the system 500 from the right side ofthe septal wall S (e.g., view from the RA). The system 500 can begenerally similar to the system 400 described above with reference toFIGS. 4A-4C. Accordingly, discussion of certain features described abovewith respect to FIGS. 4A-4C are omitted for clarity. In addition to thefeatures described above with respect to the system 400, the system 500further includes a membrane 510 encasing or otherwise coupled to atleast a portion of the shunting element 502. In some embodiments, theshape of the membrane 510 may be at least partially defined bystructural elements 520 of the shunting element 502. In someembodiments, the structural elements 520 can further serve as anchors tosecure the shunting element 502 in position and/or can define a portionof the lumen 504.

The membrane 510 can be at least partially flexible and/or impermeable,and can comprise an anti-thrombogenic, biocompatible, and/or otherwisesuitable material (e.g., silicone). The membrane 510 can, among otherthings, provide a fluid barrier to prevent blood or other fluids frominterfering with one or more components of the system 500. For example,the membrane 510 can form an enclosed chamber 512 shaped and sized tohouse various system components, such as the energy storage component532. This is in contrast with the embodiment shown in FIGS. 4A-4C, inwhich the energy storage component 432 is directly exposed to the RA. Insome embodiments, any fluid (e.g. blood) trapped under membrane 510(e.g., within chamber 512) during deployment can be evacuatedthereafter. In some embodiments, a fluid (e.g. silicon oil, a clottingagent, etc.) can be inserted into the chamber 512 after it is deployed.The fluid can provide electrical and/or thermal isolation of varioussystem components. In some embodiments, the enclosed chamber 512 isformed between the membrane 510 and a portion of the septal wall S. Insome embodiments, the housing 525 can also reside within the chamber512, although in other embodiments the housing is positioned external tothe chamber 512, such as described above with respect to FIG. 3.

The membrane 510 can also define the lumen 504 that fluidly connects theLA and the RA when the system 500 is implanted in a patient. Theflexibility of the membrane 510 can enable the shunting element 502 todynamically change in shape and or size to alter the fluid resistancethrough the lumen 504 while maintaining the fluidly isolated enclosedchamber 512 housing the various system components.

The systems described herein can include additional features notexpressly discussed above. As a non-limiting example, the systems mayinclude one or more components configured to transmit data and/or energyfrom an implanted component to a non-implanted component. For example,the systems can include a transmission element such as an antenna thatcan transmit data recorded by the implanted sensors to a display deviceexternal to the patient's body. The transmission element can beconfigured to transmit data via any suitable communication network, suchas via Bluetooth, RF communication, NF communication, WiFi, cellular, orother communication protocols. In some embodiments, the systems includemetallic portions (e.g., frame portions, anchor portions, etc.) that canbe used for energy transmission and/or receiving purposes.

As one of skill in the art will appreciate from the disclosure herein,various components of the interatrial shunting systems described abovecan be omitted without deviating from the scope of the presenttechnology. Likewise, additional components not explicitly describedabove may be added to the interatrial shunting systems without deviatingfrom the scope of the present technology. Accordingly, the systemsdescribed herein are not limited to those configurations expresslyidentified, but rather encompasses variations and alterations of thedescribed systems. Moreover, the following paragraphs provide additionaldescription of various aspects of the present technology. One skilled inthe art will appreciate that the following aspects can be incorporatedinto any of the systems described above.

C. Select Embodiments of Shunting Elements and Flow Control Mechanisms

As described above, the present technology provides interatrial shuntingsystems that can be selectively adjusted to control flow through theshunting element or device. Without wishing to be bound by theory, theadjustability of the shunting systems provided herein are expected toadvantageously address a number of challenges associated with heartfailure treatment. First, heart failure is a heterogenous disease andmany patients have various co-morbidities, and the resulting diseasepresentation can be diverse. Accordingly, a “one size fits all” approachto heart failure treatment will not provide the same therapeutic benefitto each patient. Second, heart failure is a chronic and progressdisease. Use of a non-adjustable (i.e., static) device does not permittreatment to be adapted to changes in disease progression. Theadjustable shunting systems described herein, however, are expected toadvantageously provide increased flexibility to better tailor treatmentto a particular patient and/or to various disease stages.

Additional features of various aspects of the shunting systems, such asvarious embodiments of shunting devices and flow control mechanisms, aredescribed below with respect to FIGS. 6-7C. The shunting devicesdescribed below can be adapted for use with the shunting systemsdescribed above with respect to FIGS. 2-5B. For example, any of thesystems described above can incorporate some of the features describedbelow. However, the systems described herein are not limited to theshunting devices expressly described herein. Other suitable shuntingdevices can be utilized, such as those described in International PatentApplication Nos. PCT/US2020/049996 and PCT/US2020/038549, thedisclosures of which were previously incorporated by reference herein.

FIG. 6 illustrates an exemplary adjustable interatrial shunt device 600(“device 600”) configured in accordance with embodiments of the presenttechnology. The device 600 includes an outer frame 610 and an adjustableinner lumen 630. The frame 610 includes a plurality of arms 612 defininga scaffolding for the device 600. The frame 610 can further include aplurality of RA anchors 622 and LA anchors 624. The RA anchors 622 andthe LA anchors 624 are configured to engage native heart tissue when thedevice 600 is implanted in a heart to secure the device 600 is place.The frame 610 can be encased in an outer membrane 614 suitable to engagenative heart tissue. For example, the outer membrane 614 can be abiocompatible and/or anti-thrombogenic material or fabric, such asePTFE, polyester, polyurethane, or silicone. In some embodiments, theouter membrane 614 is an elastomeric material that is at least partiallystretchable and/or flexible. The adjustable inner lumen 630 includes aproximal end portion 632 positionable within the RA of a human heart.The adjustable inner lumen 630 may extend longitudinally along thelength of the device 600, or angularly along a generally-conical planecoincident with the one or more connecting struts 640 to a distal endportion (not shown). In some embodiments, the distal end portion of theadjustable inner lumen 630 is configured to reside within the LA of theheart when the device 600 is implanted. Accordingly, in someembodiments, the adjustable inner lumen 630 can fluidly connect the LAand the RA of the heart when implanted. The adjustable inner lumen 630is defined by a plurality of struts 634 extending along the axial lengthof the lumen 630 (as shown in FIG. 6) or in an angular plane generallydefined by the conical shape encompassed by the connecting struts 640.In some embodiments, the plurality of struts 634 are generally parallelto a center axis of the lumen 630. The struts 634 can comprise ashape-memory material and/or a superelastic material such as nitinol,malleable materials such as stainless steel, cobalt chromium, or othersuitable materials. The struts 634 can be connected to the frame 610(e.g., the arms 612 of the frame 610) via one or more connecting struts640. The connecting struts 640 can also comprise a shape-memory materialand/or a superelastic material such as nitinol, malleable materials suchas stainless steel or cobalt chromium, or other suitable materials. Asdescribed below with reference to FIGS. 7A-7C, the one or moreconnecting struts 640 can be actuated to alter a position of the struts634 and change a diameter of the lumen 630 and/or lumen orifice.

The lumen 630 can further be defined by an inner membrane 633. In someembodiments, the inner membrane 633 forms a sheath around the struts 634(e.g., the struts 634 can be embedded within the inner membrane 633). Inother embodiments, the struts 634 can be positioned adjacent to but notencased within the inner membrane 633. For example, the struts 634 canbe internal to the inner membrane 633 (e.g., within the lumen 630) orexternal to the inner membrane 633 (e.g., outside the lumen 630). Whenthe struts 634 are not encased within the inner membrane 633, the struts634 can be otherwise connected to the inner membrane 633, although inother embodiments the struts 634 are not connected to the inner membrane633. Regardless of the relative positioning of the struts 634 and theinner membrane 633, the inner membrane 633 can form a single and/orcontinuous membrane with the outer membrane 614 of the frame 610 (insuch embodiments, the outer membrane 614 and the inner membrane 633 canbe collectively referred to as a single or unitary membrane). The volumeof space between the outer membrane 614 and the inner membrane 633 canform a generally toroidal shaped chamber 650, as described in greaterdetail below. The inner membrane 633 can comprise the same material asthe outer membrane 614 of the frame 610. For example, the inner membrane633 can be a biocompatible and/or anti-thrombogenic material such asePTFE and/or an elastomeric material that is at least partiallystretchable and/or flexible. For example, in an exemplary embodiment,the inner membrane 633 is ePTFE and forms a sheath around the struts634. In some embodiments, the inner membrane 633 and the outer membrane614 can comprise different materials. In some embodiments, the device600 has two, three, four, five, six, seven, eight, nine, ten, eleven,and/or twelve struts 634. As described in greater detail with respect toFIGS. 7A-7C, in some embodiments the struts 634 can be malleable and/orcontain one or more hinges, enabling the struts to dynamically changeshape (e.g., expand, fold, or otherwise bend), thereby changing thediameter of the inner lumen 630.

As described above, within embodiments the volume between the outermembrane 614 of the frame 610 and the inner membrane 633 of theadjustable inner lumen 630 defines a generally toroidal shaped chamber650. The chamber 650 can be fluidly isolated from the interior of thelumen via the inner membrane 633. The chamber 650 can also be fluidlyisolated from the environment surrounding the device 600 via the outermembrane 614. Accordingly, in some embodiments, the device is configuredto prevent blood from flowing into the chamber 650. In some embodiments,the chamber 650 can contain a compressible and/or displaceable liquid,gas, and/or gel. Accordingly, as the diameter of the lumen is adjusted,the liquid or gas can either be compressed, expanded, and/or displaced.The chamber 650 can also house one or more electronic components (e.g.,a battery, a sensor, etc.), as described above with reference to FIGS.5A-5B. In such embodiments, the electronic components can beelectrically isolated from other system components. In some embodiments,the volume between the outer membrane 614 of the frame 610 and the innermembrane 633 can be reduced or eliminated when the struts 634 areadjusted to extend only partially into the space defined by frame 610 orwhen the struts 634 are angled to align or nearly align with thegenerally-conical shaped plane defined by the connecting struts 640.

FIGS. 7A-7C schematically illustrate the adjustable inner lumen 630 ofthe device 600. Referring to FIG. 7A, the struts 634 are connected tothe frame 610 (e.g., the arms 612, shown in FIG. 6) via a firstconnecting strut 640 a at a proximal end (e.g., RA) portion and via asecond connecting strut 640 b at a position distal to the proximal end(e.g., at a location near the LA) portion (collectively referred to as“connecting struts 640”). As described above, the struts 634 at leastpartially define the shape of the lumen 630. The first connecting strut640 a can connect the struts 634 to the frame 610 at a proximalconnection 636 on the RA side of the device 600. The second connectingstrut 640 b can connect the struts 634 to the frame 610 at a distalconnection 638 that is distal to the RA side of the device 600 (e.g., onthe extreme LA side of the device 600 as shown in FIG. 7A). Thetransition between the first connecting strut 640 a and the strut 634can include a hinge or other bendable aspect 635 a (referred tohereinafter as “hinge 635 a”). Likewise, the transition between thestrut 634 and the second connecting strut 640 b can also include a hingeor bendable aspect 635 b (referred to hereinafter as “hinge 635 b”). Aswill be described below, the hinges 635 enable the strut 634 to bendand/or fold relative to the first and second connecting struts 640,thereby dynamically adjusting the diameter of the inner lumen 630.

Referring to FIG. 7A, the device 600 is shown in a first configurationin which the lumen 630 defined by the struts 634 has a first innerdiameter X₁. The frame 610 has a diameter D, and the proximal connection636 and the hinge 635 a are separated by a distance Y₁. To reduce theinner diameter of the lumen 630, the proximal end portion 632 of theinner lumen 630 moves distally (e.g., towards the LA), causing thestruts 634 to bend at hinges 635 a and 635 b. More specifically, in theillustrated embodiment, the angle defined by the first connecting strut640 a and the strut 634 at hinge 635 a is increased, while the angledefined by the second connecting strut 640 b and the strut 634 at hinge635 b is decreased. Accordingly, in various embodiments, the struts 634have a fixed length but are moveable through a range of positions by theconnecting struts 640 to change the diameter of lumen 630. In suchembodiments, the lumen 630 defined by the struts 634 remains a constantlength (e.g., length L₁ remains substantially the same), even when thediameter of the lumen 630 is changing. Moreover, L₁ may be intentionallylong such that the connecting struts 640 a and 640 b connect near the RAand LA, respectively, thereby creating a larger toroidal cavity 650.Alternatively, L₁ may be intentionally small such that the connectingstruts 640 a and 640 b may be substantially proximate to one another,thereby creating a smaller or negligible toroidal cavity 650. It will beapparent to one skilled in the art that various embodiments of thepresent technology include the mirror of the embodiment shown in FIGS.7A-7C, whereby the adjustable tapered diameter defining X₁-X₃ isoriented on the LA side rather than the RA side, and the fixed diameterD is oriented on the RA side rather than the LA side.

FIG. 7B illustrates a second configuration of device 600 in which theinner lumen 630 has a second inner diameter X₂ that is less than thefirst inner diameter X₁. The proximal connection 636 and the hinge 635 aare separated by a distance Y₂ that is less than the distance Y₁. Thediameter D of the frame 610 does not substantially change. FIG. 7Cillustrates a third configuration of device 600 in which the inner lumen630 has a third inner diameter X₃ that is less than the second innerdiameter X₂. The proximal connection 636 and the hinge 635 a areseparated by a distance Y₃ that is less than the distance Y₂. Thediameter D of the frame 610 does not change. As discussed above, thestruts 634 and/or the connecting struts 640 can comprise a shape memorymaterial. Accordingly, once the struts 634 and connecting struts 640have been transitioned to a desired position, the struts can retaintheir configuration and the lumen retains a constant diameter until anactive input is received (e.g. via an actuation mechanism, as discussedbelow).

In various embodiments, the device 600 is configured to adjust from afirst configuration or geometry to a second configuration or geometry.In the first configuration, the lumen 630 has a first substantiallyconstant diameter. In the second configuration, the lumen 630 has asecond substantially constant diameter different than the firstsubstantially constant diameter. The lumen may have a substantiallyconstant diameter along all or substantially all of its entire length.In some embodiments, however, the lumen may have a substantiallyconstant diameter along only a major portion of its length. For example,the lumen diameter may be substantially constant along the portion thatextends through the septal wall. In another example, the lumen has asubstantially constant diameter along its entire length, and hasadditional features adjacent to the lumen on one or both ends, such as aflare, funnel, taper, or the like. For example, as will be described ingreater detail below, the device 600 shows the lumen 630 having a funnelshaped inflow portion 637 configured for fluid communication with a LAof a heart (not shown) and a cylindrical shaped outflow portion 639configured for fluid communication with the right atrium of a heart (notshown).

Although FIGS. 7A-7C only illustrate three lumen diameters, one skilledin the art will appreciate that the struts 634 can be actuated through aplurality of configurations or geometries (not shown), resulting in aplurality of discrete lumen diameters (not shown). For example, thelumen 630 can take any diameter between a fully open configuration and afully closed configuration. Moreover, in addition to decreasing thediameter of the lumen 630 as illustrated, the struts 634 can beselectively actuated via the connecting struts 640 to increase thediameter of the lumen 630. To increase the diameter of the inner lumen630, the proximal end portion 632 of the inner lumen 630 movesproximally (e.g., further into the RA), such that the angle defined bythe first connecting strut 640 a and the strut 634 at hinge 635 a isdecreased, while the angle defined by the strut 634 and the secondconnecting strut 640 b at hinge 635 b is increased. Accordingly, device600 enables the diameter of the lumen 630 to by selectively adjusted tocontrol the flow of blood through the lumen 630. The specific diameterfor the lumen 630 can be selected based off the patient's needs.

In some embodiments, the device 600 can be adjusted using an inflatableballoon intravascularly delivered proximate the device 600. For example,a balloon (not shown) can be delivered via a catheter and positionedwithin the lumen 630. Inflating the balloon can push the struts 634radially outward, enlarging the lumen 630 (e.g., transitioning from theconfiguration shown in FIG. 7B to the configuration shown in FIG. 7B).The balloon can also be used to reduce the diameter of the lumen 630 bypushing the proximal end portion 632, such as at hinge 635 a, distally.

In some embodiments, the device 600 can be adjusted using an actuationassembly implanted with the device (not shown). In some embodiments, theactuation assembly is included on the device and can actively adjust theinner lumen diameter by actuating one or more of the connecting struts640, which in turn cause the struts 634 to change position. In someembodiments, for example, the actuation assembly, when actuated, pullsthe proximal end portion 632 distally, causing the struts 634 to bend asdescribed above. The actuation assembly can also be configured todirectly bend the struts 634 to alter the diameter of the lumen 630. Insome embodiments, the actuation assembly can be a motor. In addition,other materials that can convert energy to linear motion can be used(e.g., nitinol). In some embodiments, a nitinol element is coupled to apall or other mechanical element moveable via actuation of the nitinolelement.

The device 600 can include or be operably coupled to one or moresensors, as described above with reference to FIGS. 2-5B. The sensorscan be configured to detect one or more physiological parameters, suchas LA blood pressure, RA blood pressure, flow velocity, heart rate,cardiac output, myocardial strain, etc. The sensors can be, for example,(1) embedded in the device, (2) implanted yet spaced apart from thedevice (e.g., in the LA, RA, CS, etc.), and/or (3) included on awearable patch or device external to the body. In some embodiments, thewearable patch or device can also read sensor data. The sensors can becontinuously recording or can be turned on at select times. In oneembodiment, for example, the sensors are battery powered and the batteryis recharged via power harvesting. The sensors can transmit sensedphysiological parameters to external display elements, externalcontrollers, control circuitry included on the device, and/or controlcircuitry wirelessly coupled to the device. In some embodiments, forexample, sensor data (e.g., sensed physiological parameters) can be usedto actively monitor the patient and/or automatically control theadjustable devices as described herein. In another example, the sensorstransmit sensor data, such as LA and/or RA pressure, to an externaldisplay element and/or a memory storage device.

In addition to the diameter of the lumen, the shape of the lumen canalso promote flow through device 600. For example, referring back toFIGS. 7A-7C, the second connecting struts 640 b can define a funnelshaped inflow portion 637 configured for fluid communication with a LAof a heart (not shown), and the lumen 630 can include a cylindricalshaped outflow portion 639 configured for fluid communication with theRA of the heart. As illustrated in FIG. 7B, the cylindrical shapedoutflow portion 639 can have a length L₁ and the adjacent funnel shapedinflow portion 637 can have a length L₂. The diameter of the lumen 630in the cylindrical shaped outflow portion 639 along the length L₁ issubstantially constant. The substantially constant diameter of the lumen630 along the length L₁ is less than the variable diameter of the funnelshaped inflow portion 637 along the length L₂. Although length L₁ isshown as greater than length L₂ in the illustrated embodiment, otherembodiments have a length L₂ greater than length L₁. In someembodiments, length L₁ extends along a major portion of the length ofthe lumen 630, and length L₂ extends along a minor portion of the lengthof the lumen 630. In other embodiments, the struts 634 defining thecylindrical shaped outflow portion 639 extend between a distal inflowaperture and a proximal outflow aperture and there is no funnel shapedinflow portion 637. The cylindrical shaped outflow portion 639 can alsohave other non-circular cross-sectional shapes that have substantiallyconstant inner dimensions along length L₁. For example, thecross-sectional shape of the outflow portion having length L₁ can beoval, triangular, rectangular, pentagonal, etc.

When the device 600 is implanted in a heart, blood flows into the lumen630 at the funnel shaped inflow portion 637 (e.g., through the distalinflow aperture), through the cylindrical shaped outflow portion 639,and into the RA. In the exemplary embodiment, the combination of thefunnel shaped inflow portion 637 and the cylindrical shaped outflowportion 639 are expected to provide the device 600 with a number ofbeneficial flow characteristics. For example, the funnel shaped inflowportion 637 can increase blood flow into the lumen 630 from the LA. Therelatively larger distal inflow aperture allows for the gathering of alarger blood volume. Blood then flows from the relatively largerdiameter funnel shaped inflow portion 637 to the relatively smallerdiameter cylindrical shaped outflow portion 639. Based on the Venturieffect (Bernoulli's principle in mathematical terms), pressure decreasesdownstream and the flow velocity increases as the blood flows from thefunnel shaped inflow portion 637 into the relatively smaller diametercylindrical shaped outflow portion 639. In the exemplary embodiment, theoutflow portion 639 has a cylindrical shape with a substantiallyconstant diameter along length L₁. The cylindrical shaped outflowportion 639 maintains flow therethrough. By contrast, a funnel-shapedoutflow would act as a diffuser. Based on Bernoulli's Principle, anincreasing diameter on the outflow would decrease flow velocity. Theexemplary cylindrical-shaped outflow reduces swirl effects andturbulence from the inflow while also minimizing pressure increases.Combined, these effects are expected to enhance blood flow between theLA and the RA. Additionally, as illustrated in FIGS. 7A-7C, the deviceretains the funnel shaped inflow portion 637 and the cylindrical shapedoutflow portion 639 as it transitions between configurations.

One will appreciate from the description herein that other lumen shapesare possible and within the scope of the present technology. In someembodiments, for example, the lumen does not have the funnel shapedinlet portion but rather retains a substantially constant diameter alongsubstantially the entire length of the lumen. For example, the lumen canbe substantially cylindrical with a substantially constant diameterextending between the distal end portion and the proximal end portion.In other embodiments, the lumen is tapered and has a variable diameterextending between the distal end portion and the proximal end portion.For example, the lumen can have a relatively larger inflow aperture atthe distal end portion and a relatively smaller outflow aperture at theproximal end portion, with the lumen constantly tapering inward betweenthe inflow aperture and the outflow aperture to form a funnel shape. Inyet other embodiments, the lumen can have a generally hourglass shapehaving a central pinch point. As discussed above, altering the shape ofthe lumen can affect the rate of the blood flow through the lumen.Accordingly, the shape of the lumen provides an additional mechanism forfacilitating increased control over the flow of blood between the LA andthe RA through shunts configured in accordance with the presenttechnology.

FIGS. 8A-8C illustrate another adjustable interatrial shunt device 800(“device 800”) configured in accordance with select embodiments of thepresent technology. In particular, FIGS. 8A-8C are cross-sectional viewsof the device 800, and illustrate a shunting element 802 and a flowcontrol mechanism 850 for selectively changing a resistance to flowthrough the shunting element 802. Some device components and featureshave been removed from FIGS. 8A-8C for clarity. The flow controlmechanism includes a first shape memory alloy component 851, a secondshape memory alloy component 852, an actuator component 853, and aconnecting strut component 854. The shunting element 802 includes anadjustable lumen strut 805 and horizontal struts 806 which may bearranged so as to create a tubular or otherwise elongated conduitthrough the device (i.e. from a first side of the device to a secondside). FIG. 8A illustrates the device 800 in a first configuration, withfirst shape memory alloy component 851 in a first position which isrelatively compact in length and second shape memory alloy component 852in a first position which is relatively expanded in length. As a result,the actuator component 853 is biased in a position towards the left sideof the assembly, and the connecting strut component 854 is relativelyvertical. With the connecting strut component 854 in the configurationillustrated in FIG. 8A, the adjustable lumen strut 805 is angled intothe tubular conduit, resulting in a relatively narrow left-side openingof the conduit created by the horizontal struts 806. This opening may bedescribed as having a first diameter, D₁. In FIG. 8B, the device 800 isshown in a second configuration, which may be achieved after, forexample, energy stored in an energy component (not shown) has beenreleased to directly or indirectly heat the first shape memory alloycomponent 851. This heating causes the first shape memory alloycomponent 851 to change shape into a relatively expanded length, and theforce resulting from this expansion causes the second shape memory alloycomponent 852 to move to a second position which is relatively compactin length. Accordingly, the actuator component 853 is driven to a secondposition that is more biased to the right side of the assembly, and thusthe connecting strut component 854 has been moved into a second positionthat is relatively more horizontal in orientation and/or is morewell-aligned with the horizontal struts 806 that create the fluidconduit. As a result, the left-side opening of the conduit has arelatively larger second diameter, D₂. In various embodiments,components of the transseptal component may be moved (either via energyapplication methods, mechanical adjustment methods, or other methods)that change the shape or the cross-sectional diameter of one or moresections of the conduit without changing the length of the conduit(e.g., L₁=L₂).

FIG. 8C is a cross-sectional view of a variation of certain aspects ofthe device 800 described above with respect to FIGS. 8A and 8B. Manyaspects are similar to those described above in FIGS. 8A and 8B, but inthis embodiment the adjustable lumen strut 805 is an internal componentof the conduit defined by horizontal struts 806. The lumen diameter ofdevices configured as shown can be characterized by two parameters: D₃,which describes the diameter of the conduit defined by horizontal struts806, and D₄, which describes the inner diameter of the conduit definedby the position of one or more adjustable lumen struts 805. The totallength of the conduit may be described by length L₃. In variousembodiments, movement of actuator component 853 may change the diameterD₄, but the sizes/lengths/diameters described by parameters D₃ and L₃remain generally unchanged regardless of the position of the actuatorcomponent 853.

In various embodiments, a transseptal device may contain a plurality ofadjustable strut arms 805, a plurality of first and second shape memoryalloy components 851 and 852, a plurality of actuator components 853,and other components in various combinations. In various embodiments,energy that has been stored in an energy storage component (not shown)may not be delivered to a shape memory allow component directly (e.g. itmay be delivered to an intermediate component which may then transmitenergy and/or heat to the shape memory alloy component). In an example,energy stored in an energy storage component is transmitted to one ormore metallic coils which interface with sections of a shape memoryalloy component, and as the coils are heated resistively they transmitthis heat to the shape memory alloy components.

One will appreciate from the disclosure herein that other shuntingdevices, shunting elements, and flow control mechanisms can be used withthe shunting systems described herein. For example, in some embodiments,the shunting systems can include a gate-like valve that can move betweena first position blocking or at least partially blocking a flow lumenand a second position unblocking or at least partially unblocking theflow lumen. In such embodiments, the gate-like valve can be coupled toone or more shape memory elements that can be manipulated using energy,such as energy stored in an energy storage component or energy applieddirectly to the shape memory element via an energy source positionedexternal to the patient. As another example, the shunting systems caninclude one or more shape memory coils wrapped around a portion of theshunting element defining the flow lumen. The shape memory coils can beselectively wound or unwound to restrict (e.g., cinch) or relax (e.g.,uncinch) a portion of the flow lumen. In yet other embodiments, theshunting element can include a flexible bladder filled with a fluid orgas. The flexible bladder can be generally toroidal shaped such that itdefines a flow lumen therethrough. The fluid or gas can be directed intoor out of the bladder to decrease or increase the size of the lumen. Inyet other embodiments, the shunting element may incorporate at leastpartially passive concepts that can adjust a size or shape of the flowlumen based on the pressure differential between two heart chambers.Accordingly, the systems described herein are not limited to the flowcontrol mechanisms and/or shunting devices expressly described herein.Other suitable shunting devices can be utilized and are within the scopeof the present technology, such as any of those described inInternational Patent Application Nos. PCT/US2020/049996 andPCT/US2020/038549, the disclosures of which were previously incorporatedby reference herein

EXAMPLES

Several aspects of the present technology are set forth in the followingexamples:

1. A system for shunting blood between a left atrium and a right atriumof a patient, the system comprising:

-   -   a shunting element having a lumen extending therethrough between        a first orifice positionable in the left atrium and a second        orifice positionable in the right atrium, wherein the lumen is        configured to fluidly couple the left atrium and the right        atrium when the shunting element is implanted in the patient;    -   an implantable energy receiving component configured to receive        energy; and    -   an implantable energy storage component configured to be in        electrical communication with the energy receiving component,    -   wherein the energy stored within the energy storage component        can be used to selectively adjust a geometry of the lumen, the        first orifice, and/or the second orifice.

2. The system of example 1, further comprising an actuation mechanismconfigured to selectively adjust the geometry of the lumen, the firstorifice, and/or the second orifice, wherein

-   -   the energy receiving component is configured to receive energy        from an energy source positioned external to the patient; and    -   the energy storage component is further configured to (a) store        energy received by the energy receiving component and (b)        selectively release the stored energy to power the actuation        mechanism.

3. The system of example 2 wherein the actuation mechanism comprises oneor more shape memory elements, and wherein the energy storage componentis configured to release the stored energy to heat the one or more shapememory elements.

4. The system of example 2 or 3 wherein the energy receiving componentis a metallic wire configured to (i) receive energy from the energysource positioned external to the patient, and/or (ii) generate energywhen exposed to a magnetic or electric field generated by the energysource positioned external to the patient.

5. The system of example 1 wherein the energy receiving component isconfigured to receive energy released from the energy storage component,and wherein the energy received at the energy receiving component isused to selectively adjust the geometry of the lumen, the first orifice,and/or the second orifice.

6. The system of example 5 wherein the energy receiving componentincludes a shape memory actuation element configured to selectivelyadjust the geometry of the lumen, the first orifice, and/or the secondorifice.

7. The system of example 6 wherein the energy received at the energyreceiving component heats the shape memory actuation element toselectively adjust the geometry of the lumen, the first orifice, and/orthe second orifice.

8. A system for shunting blood between a left atrium and a right atriumof a patient, the system comprising:

-   -   a shunting element having a lumen extending therethrough between        a first orifice positionable in the left atrium and a second        orifice positionable in the right atrium, wherein the lumen is        configured to fluidly couple the left atrium and the right        atrium when the shunting element is implanted in the patient;    -   an actuation mechanism configured to selectively adjust a        geometry of the lumen, the first orifice, and/or the second        orifice;    -   an implantable energy receiving component configured to receive        energy from an energy source; and    -   an implantable energy storage component configured to store        energy received by the implantable energy receiving component,        wherein the implantable energy storage component is further        configured to selectively release the stored energy to power the        actuation mechanism and/or one or more active components of the        system.

9. The system of example 8 wherein, when implanted, the energy receivingcomponent and the energy storage components are configured to reside onopposite sides of a septal wall of the patient.

10. The system of example 8 or 9 wherein the energy storage componentincludes one or more tissue ingrowth features configured to promoteendothelialization of the energy storage component.

11. The system of example 10 wherein the one or more tissue ingrowthfeatures includes an external coating, a lattice structure, a roughenedsurface, and/or a mesh structure.

12. The system of any of examples 8-11 wherein the energy storagecomponent includes a battery or a capacitor.

13. The system of any of examples 8-12 wherein the energy storagecomponent is a first energy storage component, the system furthercomprising a second energy storage component.

14. The system of example 13 wherein the first energy storage componentincludes a battery and the second energy storage component includes asupercapacitor.

15. The system of any of examples 8-14 wherein the energy receivingcomponent includes a metallic wire configured to (i) receive energy fromthe energy source, and/or (ii) generate energy when exposed to amagnetic or electric field generated by the energy source.

16. The system of any of examples 8-15 wherein the energy receivingcomponent is configured to receive energy from an energy sourcepositioned external to the patient.

17. The system of any of examples 8-16 wherein the energy storagecomponent is configured to selectively release the stored energy toactuate the actuation mechanism.

18. The system of example 17 wherein the actuation mechanism comprisesone or more shape memory elements, and wherein the energy storagecomponent is configured to release the stored energy to heat the one ormore shape memory elements.

19. The system of example 18 wherein the shape memory elements have atransition temperature, and wherein the energy storage component isconfigured to release sufficient energy to heat the one or more shapememory elements to a temperature above the transition temperature.

20. The system of any of examples 8-19 wherein the shunting element hasan outer diameter and the lumen has lumen diameter, and wherein theactuation mechanism is configured to selectively adjust the lumendiameter without substantially changing the outer diameter.

21. The system of any of examples 8-20 wherein the actuation mechanismincludes a motor, and wherein the energy storage component is configuredto selectively release stored energy to power the motor.

22. The system of any of examples 8-21 wherein the one or more activecomponents include one or more sensors configured to measure one or morephysiologic parameters in the patient, and wherein the energy storageelement is configured to selectively release stored energy to power theone or more sensors.

23. The system of example 22 wherein the one or more sensors include afirst sensor implantable within the patient to measure a firstphysiologic parameter in the left atrium and a second sensor implantableinto the patient to measure a second physiologic parameter in the rightatrium.

24. The system of example 23, further comprising an implantable housingconfigured to traverse the septal wall, wherein the housing comprises:

-   -   a first end portion configured to extend into the left atrium,        wherein the first end portion houses the first sensor; and    -   a second end portion configured to extend into the right atrium,        wherein the second end portion houses the second sensor.

25. The system of example 23 or 24 wherein the first physiologicparameter is a left atrial pressure and the second physiologic parameteris a right atrial pressure.

26. The system of example 25, further comprising a processor configuredto calculate a pressure differential between the left atrium and theright atrium based, at least in part, on the measured first physiologicparameter and the measured second physiologic parameter.

27. The system of example 26, further comprising a controller configuredto direct the actuation mechanism to selectively adjust the geometry ofthe lumen, the first orifice, and/or the second orifice based at leastin part on the first and/or second physiologic parameter and/or thepressure differential between the left atrium and the right atrium.

28. The system of example 27 wherein the controller is configured toadjust the actuation mechanism if the pressure differential exceeds apredetermined upper threshold and/or falls below a predetermined lowerthreshold.

29. The system of example 27 wherein the controller is configured toadjust the actuation mechanism if a rate of change in the pressuredifferential exceeds a predetermined threshold.

30. The system of any of examples 8-29, further comprising a controller,wherein the controller is wirelessly connected to at least one of theshunting element, the actuation mechanism, the energy receivingcomponent, or the energy storage component, and wherein the controllerprovides a user interface for initiating actuation of the actuationmechanism.

31. The system of any of examples 8-30, further comprising animplantable housing, wherein the housing includes a chamber configuredfor fluid isolation from the environment external to the housing, andwherein the chamber includes one or more components of the system.

32. The system of example 31 wherein the housing has a first end portionconfigured to be positioned within the left atrium and a second endportion configured to be positioned within the right atrium.

33. The system of any of examples 8-32, further comprising a membranecoupled to the shunting element, and wherein:

-   -   the membrane defines a chamber with the septal wall when the        shunting element is implanted in the patient;    -   the chamber is fluidly isolated from the left atrium and the        right atrium; and    -   the energy receiving component, the energy storage component,        the actuation mechanism, and/or the housing are positioned        within the chamber.

34. A system for shunting blood between a left atrium and a right atriumof a patient, the system comprising:

-   -   a shunting element implantable across a septal wall of the        patient such that, when implanted in the patient, the shunting        element is configured to fluidly connect the left atrium and the        right atrium of the patient;    -   an implantable energy receiving component configured to be        positioned on a first side of the septal wall, the energy        receiving component further configured to receive energy; and    -   an implantable energy storage component configured to be        positioned on a second side of the septal wall opposite the        first side, the energy storage component further configured        to (i) store energy received by the implantable energy receiving        component, and/or (ii) selectively release stored energy to        power one or more active components of the system.

35. The system of example 34 wherein the energy storage component isconfigured to store energy received by the implantable energy receivingcomponent.

36. The system of example 34 wherein the energy storage component isconfigured to selectively release stored energy to power the one or moreactive components of the system.

37. The system of example 34 wherein the energy storage component isconfigured to (i) store energy received by the implanted energyreceiving component, and (ii) selectively release the stored energy topower the one or more active components of the system.

38. The system of any of examples 34-37 wherein the first side of theseptal wall is a left atrial side, and wherein the second side of theseptal wall is the right atrial side.

39. The system of any of examples 34-38 wherein the first side of theseptal wall is a right atrial side, and wherein the second side of theseptal wall is a left atrial side.

40. The system of any of examples 34-39 wherein the one or more activecomponents of the system includes one or more sensors configured tomeasure a physiologic parameter of the patient.

41. The system of example 40 wherein the one or more sensors areconfigured to measure blood pressure, flow velocity, pH, SpO2, SpC,SpMet, heart rate, cardiac output, and/or myocardial strain.

42. The system of any of examples 34-41 wherein the one or more activecomponents includes an actuation mechanism configured to selectivelyadjust a geometry of the shunting element.

43. The system of example 34 wherein the one or more active componentsincludes the energy receiving component, and wherein the energyreceiving component is configured to receive energy from the energystorage component.

44. The system of example 43 wherein the energy receiving componentincludes an actuation element configured to selectively adjust ageometry of the shunting element.

45. The system of any of examples 34-44 wherein the energy receivingcomponent is configured to receive energy from an energy sourcepositioned external to the patient.

46. A method for selectively controlling blood flow between a leftatrium and a right atrium in a patient using an adjustable interatrialshunting system having a lumen fluidly connecting the left atrium andthe right atrium, the method comprising:

-   -   receiving, via an implanted energy receiving component, energy        from an energy source positioned external to the patient;    -   transferring the energy received at the implanted energy        receiving component to an implanted energy storage component,        wherein the energy storage component stores the energy; and    -   selectively releasing the stored energy from the implanted        energy storage component to adjust a geometry of the lumen and        selectively alter a flow therethrough.

47. The method of example 46 wherein receiving the energy comprisesreceiving radiofrequency and/or magnetic energy.

48. The method of example 46 or 47, further comprising measuring, viaone or more sensors, one or more physiologic parameters.

49. The method of example 48, further comprising determining, based atleast in part on the one or more measured physiologic parameters, apressure differential between the left atrium and the right atrium.

50. The method of example 49 wherein adjusting the diameter of the lumenis based at least in part on the determined pressure differentialfalling outside of a predetermined range.

51. A system for shunting blood between a left atrium and a right atriumof a patient, the system comprising:

-   -   a shunting element having a lumen extending therethrough,        wherein the lumen is configured to fluidly couple the left        atrium and the right atrium when the shunting element is        implanted in the patient;    -   an energy receiving component configured to receive energy from        an energy source positioned external to the patient; and    -   an actuation mechanism configured to selectively alter a size        and/or shape of the lumen via energy received by the energy        receiving component.

52. The system of example 51, further comprising an energy storagecomponent, wherein the energy storage component is configured to storeenergy received by the energy receiving component.

53. The system of example 52 wherein the energy stored in the energystorage component can be used to actuate the actuation mechanism.

54. The system of any of examples 51-53 wherein the shunting element hasan outer diameter and the lumen has lumen diameter, and wherein theactuation mechanism is configured to selectively alter the lumendiameter without substantially changing the outer diameter.

55. The system of any of examples 51-54 wherein the shunting elementcomprises one or more shape memory elements at least partially definingthe lumen, and wherein the actuation mechanism is configured to applyenergy to the one or more shape memory elements to change the sizeand/or shape of the lumen.

56. The system of example 55 wherein the shape memory elements have atransition temperature, and wherein the actuation mechanism isconfigured to heat the one or more shape memory elements to atemperature above the transition temperature.

57. The system of example 55 or 56 wherein the energy causes a strain inthe shape memory elements along a stress-strain curve of the shapememory elements.

58. The system of any of examples 51-57 wherein the actuation mechanismcomprises one or more shape memory elements, and wherein the one or moreshape memory elements are configured to change shape to selectivelyalter the size and/or shape of the lumen.

59. The system of any of examples 51-58 wherein the actuation mechanismincludes a motor.

60. The system of any of examples 51-59, further comprising a firstsensor implantable within the patient to measure a first physiologicparameter in the left atrium and a second sensor implantable into thepatient to measure a second physiologic parameter in the right atrium.

61. The system of example 60 wherein the first physiologic parameter isa left atrial pressure and the second physiologic parameter is a rightatrial pressure.

62. The system of examples 60 or 61, further comprising a processorconfigured to calculate a pressure differential between the left atriumand the right atrium based at least in part on the measured firstphysiologic parameter and the measured second physiologic parameter.

63. The system of any of examples 60-62 further comprising a controllerconfigured to direct the actuation mechanism to selectively alter a sizeand/or shape of the lumen based at least in part on the first and/orsecond physiologic parameter and/or the pressure differential betweenthe left atrium and the right atrium.

64. The system of example 63 wherein the controller is configured toadjust the actuation mechanism if the pressure differential exceeds apredetermined upper threshold and/or falls below a predetermined lowerthreshold.

65. The system of example 63 wherein the controller is configured toadjust the actuation mechanism is a rate of change in the pressuredifferential exceeds a predetermined threshold.

66. The system of any of examples 51-65, further comprising acontroller, wherein the controller is wirelessly connected to at leastone of the shunting element, the actuation mechanism, or the energyreceiving component, and wherein the controller provides a userinterface for initiating actuation of the actuation mechanism.

67. The system of any of examples 51-66, further comprising animplantable housing, wherein the housing includes a chamber configuredfor fluid isolation from the environment external to the housing.

68. The system of example 67 wherein the housing has a first end portionconfigured to be positioned within the left atrium and a second endportion configured to be positioned within the right atrium.

69. The system of example 68 wherein the first sensor is positionedadjacent the first end portion of the housing and the second sensor ispositioned adjacent the second end portion of the housing.

70. The system of any of examples 51-69, further comprising a membranecoupled to the shunting element, wherein, when the shunting element isimplanted in the patient, the membrane defines a chamber with the septalwall, and wherein the energy receiving component, the energy storagecomponent, the actuation mechanism, and/or the housing are positionedwithin the chamber.

71. A method for selectively controlling flow between a left atrium anda right atrium in a patient using an adjustable interatrial shuntingsystem having a lumen fluidly connecting the left atrium and the rightatrium, the method comprising:

-   -   receiving energy from an energy source positioned external to        the patient; and    -   adjusting a diameter of the lumen using the energy, wherein        adjusting the diameter of the lumen alters a flow through the        lumen.

72. The method of example 71, further comprising storing the energy inan energy storage component after receiving the energy and beforeadjusting the diameter of the lumen using the energy.

73. The method of example 70 or 71 wherein receiving the energycomprises receiving radiofrequency and/or magnetic energy.

74. The method of any of examples 71-73, further comprising measuring,via one or more sensors, one or more physiologic parameters.

75. The method of example 74, further comprising determining, based atleast in part on the one or more measured physiologic parameters, apressure differential between the left atrium and the right atrium.

76. The method of example 75 wherein adjusting the diameter of the lumenis based at least in part on the determined pressure differentialfalling outside of a predetermined range.

77. A method for selectively controlling flow between a left atrium anda right atrium in a patient using an adjustable interatrial shuntingsystem having a lumen fluidly connecting the left atrium and the rightatrium, the method comprising:

-   -   receiving a signal from a signal-source positioned external to        the patient; and    -   in response to the signal, adjusting a diameter of the lumen to        alter the flow therethrough.

78. The method of example 77 wherein adjusting a diameter of the lumencomprises applying heat to one or more elements operably coupled to ordefining the lumen.

79. A septal implant, comprising:

-   -   a lumen configured to fluidly connect a first side of the septal        wall with a second side of the septal wall when the septal        implant is implanted in a heart; and    -   one or more energy storage components, wherein the one or more        energy storage components are configured to become        endothelialized by local tissues.

80. The septal implant of example 79 wherein the one or more energystorage components include an external coating configured to promoteendothelialization.

81. The septal implant of example 79 or 80 wherein the one or moreenergy storage components include an outer jacket material configured topromote endothelialization.

82. The septal implant of any of examples 79-81 wherein the energystorage components are configured to (i) store energy delivered from asource external to the body, and (ii) deliver the stored energy to aportion of the septal implant to change a shape or other characteristicof the lumen.

83. A septal implant, comprising:

-   -   an elongated tubular element configured to traverse the septal        wall and fluidly connect a first side of the septal wall with a        second side of the septal wall when implanted in a heart;    -   a first electronic component positioned on the first side of the        septal wall when the septal implant is implanted in the heart;        and    -   a second electronic component positioned on the second side of        the septal wall when the septal implant is implanted in the        heart.

84. The septal implant of example 83 wherein the first electroniccomponent is an energy receiving element and the second electroniccomponent is an energy storage element.

85. The septal implant of example 83 or 84 wherein the first electronicextends less than 6 mm away from the septal wall.

86. The septal implant of any of examples 83-85, further comprisinganchoring elements configured to secure the elongated tubular element ina desired position, wherein the first electronic component and/or thesecond electronic component are disposed between the anchoring elementsand the septal wall.

87. The septal implant of any of examples 83-86, further comprising amembrane encasing at least a portion of the septal implant andconfigured to define one or more chambers fluidly isolated form bloodwithin the heart.

88. The septal implant of example 87 wherein the first electroniccomponent and/or the second electronic component are positioned withinthe one or more chambers.

89. The septal implant of example 87 wherein the one or more chambersare configured to be at least partially filled with a fluid after theseptal implant is implanted.

90. A method for adjusting a shape of a septal implant implanted in apatient, the method comprising:

-   -   directing energy to an energy receiving component coupled with        the septal implant, wherein the energy is directed from an        energy source positioned external to the patient and stored in        the energy storage component; and    -   selectively adjusting the shape of the septal implant by        releasing stored energy from the energy storage component.

91. The method of example 90 wherein selectively adjusting the shape ofthe septal implant comprises selectively heating one or more componentsof the septal implant using the released energy.

CONCLUSION

Embodiments of the present disclosure may include some or all of thefollowing components: a battery, supercapacitor, or other suitable powersource; a microcontroller, FPGA, ASIC, or other programmable componentor system capable of storing and executing software and/or firmware thatdrives operation of an implant; memory such as RAM or ROM to store dataand/or software/firmware associated with an implant and/or itsoperation; wireless communication hardware such as an antenna systemconfigured to transmit via Bluetooth, WiFi, or other protocols known inthe art; energy harvesting means, for example a coil or antenna which iscapable of receiving and/or reading an externally-provided signal whichmay be used to power the device, charge a battery, initiate a readingfrom a sensor, or for other purposes. Embodiments may also include oneor more sensors, such as pressure sensors, impedance sensors,accelerometers, force/strain sensors, temperature sensors, flow sensors,optical sensors, cameras, microphones or other acoustic sensors,ultrasonic sensors, ECG or other cardiac rhythm sensors, SpO2 and othersensors adapted to measure tissue and/or blood gas levels, blood volumesensors, and other sensors known to those who are skilled in the art.Embodiments may include portions that are radiopaque and/orultrasonically reflective to facilitate image-guided implantation orimage guided procedures using techniques such as fluoroscopy,ultrasonography, or other imaging methods. Embodiments of the system mayinclude specialized delivery catheters/systems that are adapted todeliver an implant and/or carry out a procedure. Systems may includecomponents such as guidewires, sheaths, dilators, and multiple deliverycatheters. Components may be exchanged via over-the-wire, rapidexchange, combination, or other approaches.

The above detailed description of embodiments of the technology are notintended to be exhaustive or to limit the technology to the preciseforms disclosed above. Although specific embodiments of, and examplesfor, the technology are described above for illustrative purposes,various equivalent modifications are possible within the scope of thetechnology as those skilled in the relevant art will recognize. Forexample, although steps are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments. For example, although this disclosure has been written todescribe devices that are generally described as being used to create apath of fluid communication between the left atrium and right atrium,the left ventricle and the right ventricle, or the left atrium and thecoronary sinus, it should be appreciated that similar embodiments couldbe utilized for shunts between other chambers of heart or for shunts inother regions of the body.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Unless the context clearly requires otherwise, throughout thedescription and the examples, the words “comprise,” “comprising,” andthe like are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” As used herein, the terms “connected,”“coupled,” or any variant thereof, means any connection or coupling,either direct or indirect, between two or more elements; the coupling ofconnection between the elements can be physical, logical, or acombination thereof. Additionally, the words “herein,” “above,” “below,”and words of similar import, when used in this application, shall referto this application as a whole and not to any particular portions ofthis application. Where the context permits, words in the above DetailedDescription using the singular or plural number may also include theplural or singular number respectively. As used herein, the phrase“and/or” as in “A and/or B” refers to A alone, B alone, and A and B.Additionally, the term “comprising” is used throughout to mean includingat least the recited feature(s) such that any greater number of the samefeature and/or additional types of other features are not precluded. Itwill also be appreciated that specific embodiments have been describedherein for purposes of illustration, but that various modifications maybe made without deviating from the technology. Further, while advantagesassociated with some embodiments of the technology have been describedin the context of those embodiments, other embodiments may also exhibitsuch advantages, and not all embodiments need necessarily exhibit suchadvantages to fall within the scope of the technology. Accordingly, thedisclosure and associated technology can encompass other embodiments notexpressly shown or described herein.

1-50. (canceled)
 51. A system for shunting blood between a left atriumand a right atrium of a patient, the system comprising: a shuntingelement having a first portion positionable in the left atrium, a secondportion positionable in the right atrium, and a lumen extendingtherethrough between the first portion and the second portion, whereinthe lumen is configured to fluidly couple the left atrium and the rightatrium when the shunting element is implanted in the patient; animplantable energy receiving component configured to receive energy froman energy source; and an implantable energy storage component configuredto store energy received by the implantable energy receiving component,wherein the implantable energy storage component is further configuredto selectively release the stored energy to power one or more activecomponents of the system.
 52. The system of claim 51 wherein the one ormore active components include an actuation mechanism configured toselectively adjust a geometry of the lumen.
 53. The system of claim 52wherein the actuation mechanism includes one or more shape memoryelements, and wherein the energy storage component is configured toselectively release the stored energy to heat the one or more shapememory elements.
 54. The system of claim 51 wherein the one or moreactive components include one or more sensors configured to measure oneor more physiologic parameters in the patient.
 55. The system of claim54 wherein the one or more sensors include a first sensor implantablewithin the patient to measure a first physiologic parameter in the leftatrium, and a second sensor implantable within the patient to measure asecond physiologic parameter in the right atrium.
 56. The system ofclaim 55 wherein the first physiologic parameter is a left atrialpressure and the second physiologic parameter is a right atrialpressure.
 57. The system of claim 56, further comprising a processorconfigured to calculate a pressure differential between the left atriumand the right atrium based, at least in part, on the measured firstphysiologic parameter and the measured second physiologic parameter. 58.The system of claim 51 wherein the implantable energy storage componentincludes a battery, a capacitor, and/or a supercapacitor.
 59. The systemof claim 51 wherein the implantable energy receiving component isconfigured to receive energy from an energy source positioned externalto the patient.
 60. The system of claim 51 wherein the implantableenergy receiving component is configured to receive energy from anenergy source positioned within the patient.
 61. A system for shuntingblood between a left atrium and a right atrium of a patient, the systemcomprising: a frame configured to be anchored to a septal wall betweenthe left atrium and the right atrium of the patient; a lumen extendingthrough the frame and configured to fluidly couple the left atrium andthe right atrium when the system is implanted in the patient; one ormore implantable sensors configured to measure one or more physiologicparameters associated with the left atrium and/or the right atrium ofthe patient; and an energy receiving component configured to receiveenergy from an energy source, wherein the received energy is used topower the one or more implantable sensors.
 62. The system of claim 61,further comprising an implantable energy storage component configured tostore energy received by the energy receiving component, wherein theimplantable energy storage component is further configured toselectively release the stored energy to power the one or more sensors.63. The system of claim 61 wherein the one or more sensors include afirst sensor implantable within the patient to measure a firstphysiologic parameter in the left atrium, and a second sensorimplantable within the patient to measure a second physiologic parameterin the right atrium.
 64. The system of claim 63 wherein the firstphysiologic parameter is a left atrial pressure and the secondphysiologic parameter is a right atrial pressure.
 65. The system ofclaim 64, further comprising a processor configured to calculate apressure differential between the left atrium and the right atriumbased, at least in part, on the measured first physiologic parameter andthe measured second physiologic parameter.
 66. The system of claim 61wherein the implantable energy receiving component is configured toreceive energy from an energy source positioned external to the patient.67. The system of claim 61 wherein the implantable energy receivingcomponent is configured to receive energy from an energy sourcepositioned within the patient.
 68. A method for powering one or moreactive components of a shunting system implanted in a patient and havinga lumen configured to shunt blood between a left atrium and a rightatrium of the patient, the method comprising: receiving, via animplanted energy receiving component, energy from an energy source;transferring the energy received at the implanted energy receivingcomponent to an implanted energy storage component, wherein the energystorage component stores the energy; and selectively releasing thestored energy from the implanted energy storage component to power theone or more active components of the system.
 69. The method of claim 68wherein the one or more active components include an actuation mechanismconfigured to selectively adjust a geometry of the lumen.
 70. The methodof claim 68 wherein the one or more active components include one ormore sensors configured to measure one or more physiologic parameters inthe patient.
 71. The method of claim 70 wherein the one or more sensorsinclude a first pressure sensor implantable within the patient tomeasure left atrial pressure and a second pressure sensor implantableinto the patient to measure right atrial pressure.
 72. The method ofclaim 68 wherein receiving energy from an energy source includesreceiving energy from an energy source positioned external to thepatient.
 73. The method of claim 68 wherein receiving energy from anenergy source includes receiving energy from an energy source positionedwithin the patient.